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RecruitingPhase 1NCT05857969

Ex Vivo Drug Sensitivity Testing and Multi-Omics Profiling

Adopting a Functional Precision Medicine Approach For Individualized Pediatric Cancer Treatments

Sponsor

Florida International University

Enrollment

65 participants

Start Date

Feb 22, 2023

Study Type

INTERVENTIONAL

Conditions

Recurrent Childhood Lymphoblastic LymphomaRecurrent Childhood Acute Myeloid LeukemiaRefractory Chronic Myelogenous Leukemia, BCR-ABL1 PositiveRecurrent Childhood Acute Lymphoblastic LeukemiaRecurrent Childhood Large Cell LymphomaRefractory Childhood Acute Lymphoblastic LeukemiaRefractory Childhood Hodgkin LymphomaRefractory Childhood Malignant Germ Cell NeoplasmRecurrent Childhood Brain TumorRecurrent Childhood Brainstem GliomaRecurrent Childhood RhabdomyosarcomaRecurrent Childhood Soft Tissue SarcomaRecurrent Childhood EpendymomaRecurrent Childhood GliosarcomaRefractory Childhood Malignant Solid NeoplasmRecurrent Childhood Malignant Solid NeoplasmRecurrent Childhood Malignant NeoplasmRefractory Childhood Malignant Neoplasm

Summary

Functional precision medicine (FPM) is a relatively new approach to cancer therapy based on direct exposure of patient- isolated tumor cells to clinically approved drugs and integrates ex vivo drug sensitivity testing (DST) and genomic profiling to determine the optimal individualized therapy for cancer patients. In this study, we will enroll relapsed or refractory pediatric cancer patients with tissue available for DST and genomic profiling from the South Florida area, which is 69% Hispanic and 18% Black. Tumor cells collected from tissue taken during routine biopsy or surgery will be tested.

Eligibility

Min Age: 1 DayMax Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study is testing cancer tissue and blood samples from children and young adults with cancer that has returned or is not responding to treatment, to understand which drugs might work best for that individual's specific tumor (a personalized medicine approach called ex vivo drug sensitivity testing). **You may be eligible if...** - You are 21 years old or younger - You have a suspected or confirmed recurrent or treatment-resistant cancer - You are scheduled for a biopsy, tumor removal surgery, or bone marrow test - You (or your parents/guardians) are willing to provide consent and a blood or cheek swab sample for genetic testing **You may NOT be eligible if...** - There is not enough tumor tissue available for the required tests - You have a newly diagnosed cancer with a very high cure rate (over 90%) with standard safe therapies Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEFunctional Precision Medicine

Ex Vivo Drug Sensitivity Testing + Genomic Tumor Profiling

Locations(1)

Nicklaus Children's Hospital

Miami, Florida, United States

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NCT05857969

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